Clinical trial · Interventional
A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma
A Three-Arm Study of ME-401 Monotherapy in Subjects With Relapsed/Refractory CLL, SLL, or FL, of ME-401 in Combination With Rituximab in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination With Zanubrutinib in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): discontinuation of zandelisib program
Summary
Brief summary (as posted)
A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Diffuse Large B-cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Follicular Lymphoma (FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| High Grade Non-Hodgkin's Lymphoma | — | UNRESOLVED | — |
| Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Marginal Zone B Cell Lymphoma | Marginal Zone Lymphoma | ALIAS | 0.90 |
| Small Lymphocytic Lymphoma (SLL) | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ME-401 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ME-401 Alone
- description
- This arm is an open-label, dose escalation study to determine the safety, efficacy and pharmacokinetics of ME-401 along with the mBED, MTD, and DLTs. There are 4 planned cohorts which may enroll up to 61 subjects.
- interventionNames
- Drug: ME-401
- type
- EXPERIMENTAL
- label
- ME-401 in Combination with Rituximab
- description
- The second arm is an open label study to evaluate the safety, efficacy, and pharmacokinetics of ME-401 in combination with rituximab in subjects with various B-cell malignancies. There are two planned cohorts which may enroll up to 30 subjects.
- interventionNames
- Drug: ME-401
- Drug: Rituximab
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria MEI-401 Alone: * Diagnosis of relapsed/refractory CLL and/or relapsed/refractory SLL or FL * No prior therapy with PI3Kd inhibitors * No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy or subject had disease progression * Subjects with CLL/SLL must have prior treatment with BTK inhibitor and must have had progression or recurrence while on treatment of within 12 mos from BTK treatment * Subject must have failed at least 1 prior systemic therapy * QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (ms) * Left ventricular ejection fraction \> 50% * For subjects, except those with CLL, must have at least one bi-dimensionally measurable nodal lesion \>1.5 cm, as defined by Lugano Classification * Willingness to participate in collection of pharmacokinetic samples * A negative serum pregnancy test within 14 days of study Day 0, for females of childbearing potential Inclusion Criteria ME-401 in Combination with Rituximab * Diagnosis of relapsed/refractory CLL SLL or FL, MZL, DLBCL and high-grade B-cell lymphoma. Subjects must meet the following criteria for relapsed or refractory disease: * No prior therapy with PI3Kδ inhibitors * No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy or subject had disease progression * Subjects with CLL, SLL, FL, and MZL must have a failure of at least 1 prior systemic therapy and be considered by the investigator a candidate for therapy with a rituximab-based regimen; subjects with DLBCL and high-grade B-cell lymphoma must have a failure of at least 2 prior therapies. * QT-interval corrected according to Fridericia's formula (QTcF) ≤450 milliseconds (ms) * Left ventricular ejection fraction \> 50% * For subjects, except those with CLL, must have at least one bi-dimensionally measurable nodal lesion \>1.5 cm, as defined by Lugano Classification * Willingness to participate in collection of pharmacokinetic samples * A negative serum pregnancy test within 14 days of study Day 0 for females of childbearing potential Inclusion Criteria ME-401 in Combination with Zanubrutinib * Diagnosis of relapsed/refractory CLL or histologically-confirmed relapsed/refractory SLL or FL, MZL, MCL, DLBCL NOS (germinal center B-cell type or activated B-cell type) * No prior therapy with PI3Kδ inhibitors * No prior therapy with BTK inhibitors * Subjects with CLL, SLL, FL, MCL, and MZL must have a failure of at least 1 prior systemic therapy, require treatment in the opinion of the investigator, and be considered by the investigator a candidate for therapy subjects with DLBCL and high-grade B-cell lymphoma must have a failure of at least 2 prior therapies * For subjects with SLL, FL, MZL, MCL, DLBCL: At least one bi dimensionally measurable nodal lesion \> 1.5 cm in its longest diameter by CT scan or MRI * QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec) * Left ventricular ejection fraction \> 50% as measured by echocardiogram or multigated acquisition (MUGA) scan * Willingness to participate in collection of pharmacokinetic samples * For females of childbearing potential, a negative serum pregnancy test within 14 days of study Day 0 Exclusion Criteria: * Known histological transformation from CLL to an aggressive lymphoma * Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia * Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody * Positive for hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody * Ongoing drug-induced pneumonitis * History of clinically significant cardiovascular abnormalities * History of severe bleeding disorders (ME-401 plus zanubrutinib arm only) * Known central nervous system (CNS) hemorrhage or stroke within 6 months prior to start of study drugs (ME-401 plus zanubrutinib arm only)
References
Publications (1)
- DERIVEDPagel JM, Soumerai JD, Reddy N, Jagadeesh D, Stathis A, Asch A, Salman H, Kenkre VP, Iasonos A, Llorin-Sangalang J, Li J, Zelenetz AD. Zandelisib with continuous or intermittent dosing as monotherapy or in combination with rituximab in patients with relapsed or refractory B-cell malignancy: a multicentre, first-in-patient, dose-escalation and dose-expansion, phase 1b trial. Lancet Oncol. 2022 Aug;23(8):1021-1030. doi: 10.1016/S1470-2045(22)00333-3. Epub 2022 Jul 11. PMID 35835137